Axinn successfully advocated that FDA should preserve the 180-day marketing exclusivity period relating to a generic version of SmithKline’s Coreg CR (carvedilol phosphate extended-release capsules) even though it took the ANDA applicant over 10 years to obtain tentative approval of its product.  Through a series of correspondence submitted to FDA over the course of a number of years, Axinn successfully convinced FDA that the 180-day exclusivity period was not forfeited by Mutual Pharmaceutical Company (now Sun Pharma) because of a change in the approval requirements for the product. 

Click here to read FDA's decision and here to read press coverage on FDA Law Blog.